Sab Simplex - drops

Gas accumulation in the gastrointestinal tract can occur in various ways, e.g. through improper nutrition, flatulent foods, indigestion, but also by swallowing air.

Application

What is Sab Simplex and what is it used for?

Gas accumulation in the gastrointestinal tract can occur in various ways, e.g. through improper nutrition, flatulent foods, indigestion, but also by swallowing air. Especially in infants and toddlers, flatulence often occurs due to hasty drinking. The gas accumulation in the gastrointestinal tract is then found as small-bubbled, sluggish foam. The active ingredient of Sab Simplex, simethicone, causes the foam to disintegrate. This allows the intestinal gases to pass naturally. The active ingredient itself is not absorbed into the bloodstream, but is excreted unchanged. 25 drops correspond to 1 ml.

Used for:
excessive gas formation and gas accumulation in the gastrointestinal area with symptoms such as flatulence, a feeling of fullness and tension in the upper abdomen

Use after consultation with the attending physician:
in case of increased gas formation after operations
for the preparation of diagnostic examinations in the abdominal area to reduce gas shadows (X-ray, sonography) and for the preparation of gastrointestinal endoscopies
for defoaming in case of dishwashing detergent poisoning

How is it used?

What is Sab Simplex and what is it used for?

Gas accumulation in the gastrointestinal tract can occur in various ways, e.g. through improper nutrition, flatulent foods, indigestion, but also by swallowing air. Especially in infants and toddlers, flatulence often occurs due to hasty drinking. The gas accumulation in the gastrointestinal tract is then found as small-bubbled, sluggish foam. The active ingredient of Sab Simplex, simethicone, causes the foam to disintegrate. This allows the intestinal gases to pass naturally. The active ingredient itself is not absorbed into the bloodstream, but is excreted unchanged. 25 drops correspond to approx. 1 ml.

Used for:
- excessive gas formation and gas accumulation in the gastrointestinal area with symptoms such as flatulence, a feeling of fullness and tension in the upper abdomen

Use after consultation with the attending physician:
- in case of increased gas formation after operations
- for the preparation of diagnostic examinations in the abdominal area to reduce gas shadows (X-ray, sonography) and for the preparation of gastrointestinal endoscopies
- for defoaming in case of dishwashing detergent poisoning

Sab Simplex is used in adults, adolescents and children from 1 month of age.

If you do not feel better or even worse, contact your doctor.

What should you consider before taking it?

What should you consider before taking Sab Simplex?

Sab Simplex must not be taken,
- if you or your child are allergic to simethicone or any of the other ingredients of this medicine listed in section 6.
Warnings and precautions
Please talk to your doctor or pharmacist before taking Sab Simplex.
If you experience new and/or persistent or worsening abdominal pain, you should see a doctor so that the cause of the pain can be identified.
Taking Sab Simplex with other medicines
Tell your doctor or pharmacist if you or your child are taking, have recently taken or intend to take any other medicines.

In particular, you should inform your doctor or pharmacist if you or your child are taking:
- Levothyroxine (for the treatment of an underactive thyroid gland [hypothyroidism]).
Since Sab Simplex can affect your treatment with levothyroxine, you should wait at least 4 hours between
taking these medicines.

Taking Sab Simplex with food and drink
No interactions are known. It is best to take Sab Simplex with or after meals, or before going to bed if necessary.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Since simethicone is not absorbed through the digestive tract, Sab Simplex can be taken during pregnancy and breastfeeding.

Driving and using machines
Sab Simplex has no influence on the ability to drive and use machines.

Sab Simplex contains sodium benzoate, alcohol (ethanol) and sodium
This medicine contains 1 mg sodium benzoate per 1 ml (approx. 25 drops). Sodium benzoate can increase the concentration of a substance called bilirubin.

1 ml (approx. 25 drops) of this medicine contains 0.18 mg of alcohol (ethanol) in the raspberry flavouring. The
amount of alcohol per 1 ml of this medicine corresponds to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine has no noticeable effects.

A 30 ml bottle of this medicine contains 92.1 mg of sodium (main component of cooking salt/table salt). 1 ml (approx. 25 drops) of this medicine contains 3.07 mg of sodium. This corresponds to 0.15% of the maximum daily intake of sodium recommended for an adult with food.

Note
Sab Simplex is suitable for diabetics as it contains no carbohydrates.

How should the medicine be taken?

How should Sab Simplex be taken?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

For oral use.
Shake the bottle well before use! To drop, hold the bottle vertically downwards and tap the bottom of the bottle lightly with your finger. The speed of the drops can be reduced by tilting the bottle.
The following dosages apply to the treatment of flatulence and a feeling of fullness:

Infants and children (≤ 6 years):
The dose should be taken 4 to 6 times a day, i.e. every 4 to 6 hours.

For children over 12 months up to ≤ 6 years, the interval between doses can be shortened.

Age	Single dose
Infants (> 4 weeks to≤12 months)	15 drops (0.6 ml)
Children (> 12 months to≤6 years)	15 drops (0.6 ml)

Sab Simplex can be added to the bottle for infants. It mixes easily with other liquids, e.g. with milk.
Sab Simplex can also be administered with a small spoon before breastfeeding/feeding.Premature babies should not be treated with Sab Simplex.
For children over 12 months up to ≤ 6 years, Sab Simplex is taken with or after meals, or before going to bed if necessary.

Children and adolescents (> 6 years to < 18 years) and adults:
The dose should be taken 4 to 6 times a day, i.e. every 4 to 6 hours. If necessary, the time interval between doses can be shortened.

Sab Simplex is taken with or after meals, or before going to bed if necessary.

Age	Single dose
Children and adolescents (> 6 years to < 18 years)	20 to 30 drops (0.8 to 1.2 ml)
Adults	30 to 45 drops (1.2 to 1.8 ml)

Duration of use:
The duration of use of Sab Simplex depends on the course of the symptoms. If the symptoms persist or worsen, consult your doctor or pharmacist.

Administration for the following indications (after consultation with your doctor) is best done after removing the dropper insert from the bottle:

For preparation for an X-ray examination, 3 to 6 teaspoons (15 to 30 ml) of Sab Simplex should be taken on the evening before the examination.

For preparation for ultrasound examination (sonography), it is recommended to take 3 teaspoons
(15 ml) of Sab Simplex on the evening before and 3 teaspoons (15 ml) approx. 3 hours before the start of the examination.

Before gastrointestinal endoscopies, ½ to 1 teaspoon (2.5 to 5 ml) of Sab Simplex should be taken.

In dishwashing detergent poisoning, the dosage depends on the severity of the poisoning. The smallest recommended dose is 1 teaspoon (5 ml) of Sab Simplex.
If you have taken more Sab Simplex than you should
When taken orally, Sab Simplex is harmless. Even when very high doses are used, no damage is to be expected.

If you forget to take Sab Simplex
Do not take twice the amount if you have forgotten to take the previous dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What side effects are possible?

What side effects are possible?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in connection with the
use of Sab Simplex, classified by organ systems; currently, no frequency data for these side effects are available, i.e. the frequencies are not known (frequency not estimable from the available data):

Immune system disorders
Hypersensitivity reactions

Gastrointestinal disorders
Abdominal pain, diarrhoea, vomiting

Skin and subcutaneous tissue disorders
Redness, rash

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system:
Federal Office for Safety in Health Care
Traisengasse 5
1200 VIENNA
AUSTRIA
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at/
By reporting side effects, you can help provide more information on the safety of this medicine.

Special storage instructions

How should Sab Simplex be stored?

This medicinal product does not require any special storage conditions.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label "Use by" and carton "Usable until". The expiry date refers to the last day of the month indicated.

After opening the glass bottle, the medicine should be used within one month.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

Special information on the content

Contents of the pack and further information

What Sab Simplex contains

- The active substance is simethicone. 1 ml (approx. 25 drops) contains 69.19 mg simethicone (dimethicone 350-silicon dioxide 92.5 : 7.5).
- The other ingredients are ceto-macrogol, sorbic acid, hypromellose, sodium citrate, citric acid, vanilla flavouring (H&R [60388]), carbomer, sodium cyclamate, raspberry flavouring (H&R [60373]) (contains ethanol), sodium benzoate (E 211), saccharin sodium, purified water.

What Sab Simplex looks like and contents of the pack

White to greyish-white, slightly viscous emulsion for oral use with vanilla-raspberry flavour.
The drops are available in 30 ml brown glass bottles with a plastic dropper and a white plastic cap in a cardboard box.